PALEXIA 20 mg/ml ORAL SOLUTION

2. What you need to know before you take Palexia

Do not take Palexia:

• if you are allergic to tapentadol or any of the other ingredients of this medicine (listed in section 6),
• if you have asthma or if your breathing is slow or shallow to dangerous levels [respiratory depression; hypercapnia (elevated carbon dioxide levels in the blood)],
• if you have a disease in which the intestine does not function properly (paralytic ileus),
• if you have consumed alcohol, sleeping pills, other pain relievers, or other psychotropic medicines (medicines that affect mood and emotions) at high doses (see section "Taking Palexia with other medicines").

Warnings and precautions

Consult your doctor or pharmacist before taking Palexia:

• if your breathing is slow or shallow,
• if you have increased intracranial pressure or altered consciousness up to coma,
• if you have had a head injury or brain tumors,
• if you have liver or kidney disease (see section "How to take Palexia"),
• if you have a disease of the pancreas (such as pancreatitis) or the bile ducts,
• if you are taking medicines called mixed opioid agonist/antagonists (e.g., pentazocine, nalbuphine) or partial agonists of the opioid μ-receptors (e.g., buprenorphine),
• if you are prone to epilepsy or convulsive seizures, or if you are taking other medicines with a known risk of increasing seizures, as the risk of these seizures may increase,
• if you or a family member have a history of substance abuse or dependence on prescription medicines or illicit substances ("addiction"),
• if you smoke,
• if you have ever had problems with your mood (depression, anxiety, or personality disorder) or have received psychiatric treatment for other mental illnesses.

This medicine contains tapentadol, which is an opioid medicine. Repeated use of opioid pain relievers can lead to a decrease in their effectiveness (you may get used to it). It can also lead to dependence and abuse, which can result in a potentially life-threatening overdose. It is essential that you inform your doctor if you think you may have developed dependence on Palexia. Its use (even at therapeutic doses) can cause physical dependence, which may lead to withdrawal symptoms and a recurrence of your problems if you stop taking this treatment abruptly.

Palexia can cause physical and psychological dependence. If you have a tendency to abuse medicines or have a history of drug dependence, you should only take this medicine for short periods under strict medical supervision.

Children with obesity should be closely monitored, and the maximum recommended dose should not be exceeded.

Do not give this medicine to children under 2 years of age or with a body weight below 16 kg.

Sleep-related breathing disorders

Palexia can cause sleep-related breathing disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to difficulty breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, consult your doctor. Your doctor may consider reducing the dose.

Taking Palexia with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• The risk of side effects increases if you are taking medicines that can cause seizures (attacks), such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Palexia simultaneously with these medicines. Your doctor will tell you if Palexia is suitable for you.

• Taking Palexia with sedative medicines such as benzodiazepines or related medicines (certain sleeping pills or tranquilizers [e.g., barbiturates] or pain relievers like opioids, morphine, and codeine [also as a cough medicine], antipsychotics, antihistamines H1, alcohol) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be potentially life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes Palexia with sedative medicines, they will limit the dose and duration of concomitant treatment.

Taking opioids with medicines used to treat epilepsy, nerve pain, or anxiety (gabapentin and pregabalin) increases the risk of opioid overdose, respiratory depression, and can be potentially life-threatening.

Tell your doctor if you are taking gabapentin or pregabalin or any other sedative medicine and follow your doctor's dosage recommendation to the letter. It may be helpful to inform your friends and family about the signs and symptoms mentioned above. Tell your doctor if you experience any of these symptoms.

If you are taking a type of medicine that affects serotonin levels (e.g., certain medicines for treating depression), talk to your doctor before taking Palexia, as there have been cases of "serotonin syndrome". Serotonin syndrome is a rare but potentially life-threatening disorder. Symptoms can include involuntary muscle contractions, including muscles that control eye movement, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Your doctor can provide you with more information.

• The concomitant administration of Palexia with other types of medicines called mixed opioid agonist/antagonists (e.g., pentazocine, nalbuphine) or partial agonists of the opioid μ-receptors (e.g., buprenorphine) has not been studied. It is possible that Palexia may not have the same efficacy if administered with one of these medicines. Inform your doctor if you are currently being treated with one of these medicines.

• Administration of this medicine with potent inhibitors or inducers (e.g., rifampicin, phenobarbital, St. John's Wort) of certain enzymes necessary for the elimination of tapentadol from your body may affect the efficacy of tapentadol or may cause side effects, especially when starting or stopping this other type of medication. Keep your doctor informed about all the medicines you are taking.

• Palexia must not be taken with MAO inhibitors (medicines for treating depression). Tell your doctor if you are taking MAO inhibitors or if you have taken them in the last 14 days.

Taking Palexia with food, drinks, and alcohol

Do not consume alcohol while taking this medicine, as some of its side effects, such as drowsiness, may increase. The intake of food does not affect the effect of this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take this medicine:

• if you are pregnant, unless your doctor has told you to do so. If used during prolonged periods during pregnancy, tapentadol may cause withdrawal symptoms in the newborn, which can be life-threatening if not detected and treated by a doctor.

Palexia is not recommended:

• during labor, as it may cause slow or shallow breathing to dangerous levels (respiratory depression) in the newborn,
• during breastfeeding, as tapentadol may be excreted in breast milk.

Driving and using machines

Ask your doctor if you can drive or use machines during treatment with tapentadol. It is essential that you observe how this medicine affects you before driving or using machines. Do not drive or use machines if you feel drowsy, dizzy, have blurred vision, or have difficulty concentrating. Be particularly careful when starting treatment, after a dose change, and when taking it in combination with alcohol or tranquilizers.

Palexia contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose unit, which is essentially "sodium-free".

Palexia contains sodium benzoate

This medicine contains 5.9 mg of sodium benzoate in 5 ml of oral solution (maximum dose unit), which is equivalent to 1.18 mg/ml.

Benzoic acid salt may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

Palexia contains propylene glycol

This medicine contains 10 mg of propylene glycol in 5 ml of solution (maximum dose unit), which is equivalent to 2 mg/ml.

3. How to take Palexia

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will adjust the dose based on the intensity of your pain and your personal level of sensitivity to pain. You should generally take the minimum effective dose to relieve pain.

Adults

The recommended dose is 50 mg of tapentadol (2.5 ml of oral solution), 75 mg of tapentadol (3.75 ml of oral solution), or 100 mg of tapentadol (5 ml of oral solution) every 4 or 6 hours.

Daily total doses above 700 mg of tapentadol on the first day of treatment or daily doses above 600 mg of tapentadol on subsequent days of treatment are not recommended.

Your doctor may prescribe a different dose or dosing regimen if necessary. If you think the effect of this medication is too strong or too weak, consult your doctor or pharmacist.

Elderly patients

In elderly patients (over 65 years of age), the dose does not usually need to be adjusted. However, the elimination of tapentadol may be delayed and slower in certain patients in this age group. If this happens to you, your doctor may prescribe a different dosing regimen.

Liver and kidney diseases (hepatic and renal insufficiency)

Patients with severe liver problems should not take this medication. If you have moderate liver problems, your doctor will prescribe a different dosing regimen. In case of mild liver problems, no dose adjustment is necessary.

Patients with severe kidney problems should not take this medication. In case of mild or moderate kidney problems, no dose adjustment is necessary.

Use in children and adolescents

This medication should only be administered to children in the hospital. This medication should only be administered to children with a body weight of more than 16 kg.

The dose of Palexia for children and adolescents from 2 years to 18 years is 1.25 mg/kg every 4 hours.

Always wait 4 hours before giving the next dose. The dose can be reduced as acute pain decreases.

The correct administration will be determined by your doctor.

Liver and kidney diseases (hepatic and renal insufficiency)

Children and adolescents with liver or kidney problems should not take this medication.

How and when to take Palexia

This medication should be taken orally.

You can take the oral solution on an empty stomach (fasting) or with meals.

The package contains a dosing syringe with an adapter that must be used to extract the exact amount (volume) from the bottle corresponding to the prescribed dose of tapentadol.

Instructions for opening the bottle and using the dosing syringe

The bottle has a child-resistant screw cap. To remove the cap, press it down and turn it counterclockwise (Fig. 1). Remove the cap and peel off the security seal from the top of the bottle. If the security seal is damaged, do not use this medication and consult your pharmacist.

Fig. 1

Place the bottle on a firm and smooth surface. Open the plastic bag containing the dosing syringe and adapter at the perforated end and remove the dosing syringe (A) and adapter (B), both included. Insert the dosing syringe into the adapter and place it firmly on the neck of the bottle (Fig. 2).

Fig. 2

To fill the dosing syringe, turn the bottle upside down. While keeping the dosing syringe in place, gently pull the plunger (C) down to the line that matches the dose prescribed by your doctor (see the section "How to take Palexia"). Do not removethe dosing syringe yet! (Fig. 3).

Fig. 3

Turn the bottle back to its vertical positionand carefully remove the dosing syringe from the bottle. Once the dosing syringe is removed, carefully check that you have extracted the correct amount of solution. The adapter (B) that was previously attached to the dosing syringe should now remain in the bottle (Fig. 4).

Fig. 4

To take the medication, place the dosing syringe in your mouth and press the plunger gently. Press the plunger to the end to ensure you take the entire solution. If you prefer, you can dilute the medication in a glass of water or a non-alcoholic beverage before taking it, in which case you must take the entire glass to ensure you take the correct dose of the medication (Fig. 5).

Fig. 5

Leave the adapter in the bottle, close the bottle firmly, and store it in a vertical position. Rinse the dosing syringe with water after each use and let it dry. The next time you take the medication, place the dosing syringe in the adapter that will be on the neck of the bottle and follow the instructions mentioned above.

How long to take Palexia

Do not take this medication for longer than your doctor has indicated.

If you take more Palexia than you should

After taking very high doses, you may experience some of the following effects:

• very small pupils, vomiting, decreased blood pressure, rapid heartbeat, fainting, altered consciousness or coma (deep loss of consciousness), epileptic seizures, slow or shallow breathing to dangerous levels or respiratory arrest.

If any of these things happen to you, call a doctor immediately!

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used. It is recommended to take the package and the medication's prospectus to the healthcare professional.

If you forget to take Palexia

If you forget to take this medication, you will likely feel pain again. Do not take a double dose to make up for forgotten doses, but continue taking this medication as before.

If you stop treatment with Palexia

If you stop or discontinue treatment too soon, you will likely feel pain again. If you want to stop treatment, consult your doctor before doing so.

Generally, patients do not experience any adverse effects after stopping treatment, but in rare cases, people who have taken this medication for a long time may feel unwell if they stop taking it suddenly.

The symptoms may be:

• restlessness, tearful eyes, runny nose, yawning, sweating, chills, muscle pain, and dilated pupils,
• irritability, anxiety, back pain, joint pain, weakness, abdominal cramps, difficulty sleeping, nausea, loss of appetite, vomiting, diarrhea, and increased blood pressure, respiratory rate, or heart rate.

If you experience any of these symptoms after stopping treatment, consult your doctor.

You should not stop taking this medication abruptly, unless your doctor tells you to do so. If your doctor wants you to stop taking this medication, they will indicate how to do so, which may involve a gradual reduction in dose.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Important side effects or symptoms to be aware of and what to do if you are affected by them:

This medication can cause allergic reactions. The symptoms may include wheezing (a type of whistling when breathing), difficulty breathing, swelling of the eyelids, face, or lips, skin rash, or itching, especially if it affects the whole body.

Another serious side effect is feeling drowsy and breathing more slowly or weakly than normal. This occurs mainly in elderly or debilitated patients.

If you experience any of these important symptoms, consult your doctor immediately.

Side effects that may occur:

Very common(may affect more than 1 in 10 people): nausea, vomiting, dizziness, drowsiness, headache.

Common(may affect up to 1 in 10 people): decreased appetite, anxiety, confusion, hallucinations, difficulty sleeping, sleep disturbances, tremors, hot flashes, constipation, diarrhea, indigestion, dry mouth, itching, increased sweating, skin rash, muscle cramps, feeling of weakness, fatigue, feeling of change in body temperature.

Uncommon(may affect up to 1 in 100 people): depression, disorientation, excitability (agitation), nervousness, restlessness, euphoric mood, attention disturbances, memory impairment, feeling of being about to faint, sedation, difficulty controlling movements, difficulty speaking, numbness, abnormal skin sensations (e.g., tingling, itching), muscle twitches, vision disturbances, rapid heartbeat, palpitations, decreased blood pressure, slow or shallow breathing to dangerous levels (respiratory depression), decreased oxygen levels in the blood, shortness of breath, abdominal discomfort, rash, feeling of heaviness, urinary retention, frequent urination, drug withdrawal syndrome (see section "If you stop treatment with Palexia"), water retention in the tissues (edema), feeling of discomfort, feeling of intoxication, irritability, feeling of relaxation.

Rare(may affect up to 1 in 1,000 people): allergic reaction to medications (including swelling under the skin, urticaria, and in severe cases difficulty breathing, decreased blood pressure, collapse, or shock), altered thinking, epileptic seizures, decreased level of consciousness, altered coordination, slow heartbeat, altered gastric emptying.

Frequency not known:delirium.

In general, the possibility of having suicidal thoughts and behaviors increases in patients with chronic pain. Additionally, some medications for treating depression (with an impact on the brain's neurotransmitter system) may increase this risk, especially at the start of treatment. Although tapentadol also affects neurotransmitters, experience in patients has not shown that it increases this risk.

No additional side effects have been observed in children and adolescents.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Palexia

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date shown on the box and on the bottle after CAD. The expiration date is the last day of the month indicated.

Before the first opening: this medication does not require special storage conditions.

The solution should not be used six weeks after the first opening of the bottle.

Store in a vertical position after the first opening.

Medications should not be thrown away through the drains or in the trash. Deposit the packages and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Palexia

The active ingredientis tapentadol.

1 ml of oral solution contains 20 mg of tapentadol (in the form of hydrochloride).

The othercomponents are:

Sodium benzoate (E211)

Citric acid monohydrate

Sucralose (E955)

Raspberry flavor, contains propylene glycol (E1520)

Sodium hydroxide (for pH adjustment)

Purified water

Appearance of the product and package contents

Palexia is a clear and colorless oral solution.

The oral solution is supplied in plastic bottles containing 100 milliliters or 200 milliliters of solution and includes a 5 ml dosing syringe graduated in 0.1 ml fractions and an adapter attached to the dosing syringe. Additionally, the scale on the right shows the unit dose for adults.

Only certain package sizes may be marketed.

Marketing authorization holder

Grünenthal Pharma, S.A.

Doctor Zamenhof, 36 – 28027 Madrid, Spain

Manufacturer

Grünenthal GmbH

Zieglerstrasse, 6 – D-52078 Aachen, Germany

This medication is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Austria, Germany, Belgium, Cyprus, Croatia, Slovenia, Spain, Greece, Netherlands, Ireland, Italy, Luxembourg, Norway, Poland, Portugal, Czech Republic, Slovakia, United Kingdom (Northern Ireland): Palexia

Date of the last revision of this prospectus:July 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/